Self-contained test sensor

ABSTRACT

A test strip to assist in determining the concentration of an analyte in a fluid sample comprises a base, at least one tab and a break line. The base includes a capillary channel and a test element. The capillary channel is in fluid communication with the test element. The test element is adapted to receive the fluid sample. The at least one tab is removably attached to the base. The capillary channel extends from the base into a portion of the tab. The break line intersects the capillary channel in which an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

This application is a continuation of U.S. application Ser. No.11/792,360, filed Jun. 5, 2007, now U.S. Pat. No. 8,691,161, which wasthe National Stage of International Application No. PCT/US2005/044810,filed Dec. 12, 2005, which claims the benefit of U.S. ProvisionalApplication No. 60/635,721 filed Dec. 13, 2004, each of which is herebyincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to diagnostic instruments and,more particularly, to individually desiccated diagnostic test strips anda method for using the same.

BACKGROUND OF THE INVENTION

Test strips (e.g., biosensors) containing reagents are often used inassays for determining the analyte concentration in a fluid sample. Thequantitative determination of analytes in body fluids is of greatimportance in the diagnoses and maintenance of certain physiologicalabnormalities. For example, lactate, cholesterol, and bilirubin shouldbe monitored in certain individuals. In particular, determining glucosein body fluids is important to diabetic individuals who must frequentlycheck the glucose level in their body fluids to regulate the glucoseintake in their diets. Each test requires that a new test sensor beused, and thus, a number of test strips may be used in a single day.Cartridges that contain a number of test strips are used to allow usersto carry multiple strips around within a single object. These cartridgesmay also be incorporated directly into a meter.

One of the difficulties in designing a meter or cartridge containingmultiple test stripes in a compact housing (stacked like sticks ofchewing gum in a package) is how to provide the desiccation required toprevent or inhibit strip deterioration. If the cartridge or meter itselfis the primary container, the adequate resealing of the package once thefirst test strip is removed is a problem. If each test strip isindividually foiled, the foil (a) may get in the way of strip handlingand/or (b) make it more difficult to automatically move or discard thestrip with a device.

One approach to individual test strip desiccation is to individuallypackage the test strips as a continuous reel. This approach generates alot of trash from the packaging that is fed back into the stripcartridge. This trash provides an increased likelihood of misfeeding thepackaging scrap, thus, resulting in jams. This approach also mandates alarger package to accommodate the trash. Alternatively, another approachis to create separated individual compartments within the cartridge ormeter. However, this approach does not provide for efficient stacking oftest strips in a compact housing. Another approach is to foil the teststrips with an individual desiccant. Typically, in this approach, thedesiccant is outside of the test strip itself. Additionally, a lot ofexcess packaging (the foil) is required whose removal is difficult tointegrate with an automatic strip feed system.

Therefore, it would be desirable to have a system and method fordesiccating a diagnostic test strip that addresses these issues.

SUMMARY OF THE INVENTION

A test strip to assist in determining the concentration of an analyte ina fluid sample is disclose, according to one embodiment of the presentinvention. The test strip includes a base including a capillary channeland a test element. The capillary channel is in fluid communication withthe test element and the test element is adapted to receive the fluidsample. The test strip includes at least one tab removably attached tothe base. The capillary channel extends from the base into a portion ofthe tab. The test strip further includes a break line intersecting thecapillary channel. An inlet to the capillary channel is exposed alongthe break line when the tab is separated from the base.

According to another embodiment of the present invention, a method forusing a test strip to determine a concentration of an analyte in a fluidsample is disclosed. The method includes the act of providing a teststrip including (i) a base including a capillary channel and a testelement, (ii) at least one tab removably attached to the base, and (iii)a break line intersecting the capillary channel. The capillary channelis in fluid communication with the test element that is adapted toreceive the fluid sample. The capillary channel extends from the baseinto a portion of the tab. The method further includes the act ofexposing an inlet to the capillary channel by at least partiallyseparating the at least one tab from the base.

According to yet another embodiment of the present invention, a teststrip to assist in determining the concentration of an analyte in afluid sample is disclosed. The test strip includes a base including acapillary channel and a test element. The capillary channel is in fluidcommunication with the test element that is adapted to receive the fluidsample. The test strip further includes a tab removably attached to thebase. The capillary channel extends from the base into a portion of thetab. The test strip further includes a protrusion extending from thebase into the tab. The protrusion is an extension of the capillarychannel into the tab. The test strip further includes a break lineintersecting the capillary channel. An inlet to the capillary channel isexposed when the tab is separated from the base. The inlet is located atthe end of the protrusion opposite the base.

According to one embodiment of the present invention, a test strip toassist in determining the concentration of an analyte in a fluid sampleis disclosed. The test strip includes a base and at least one tab. Thebase includes an upper surface, a capillary channel, a test element, anda desiccant. The capillary channel is in fluid communication with thetest element that is adapted to receive the fluid sample. The at leastone tab is removably attached to the upper surface of the base. The atleast one tab includes a lip that extends from the base. The lip isadapted to allow the at least one tab to be separated such that theseparation from the base exposes an inlet to the capillary channel.

According to another embodiment of the present invention, a test stripto assist in determining the concentration of an analyte in a fluidsample is disclosed. The test strip includes a base including acapillary channel, a test element, and a vent channel. The test elementis adapted to receive the fluid sample. The capillary channel, testelement, and vent channel are in communication with one another. Thetest strip includes a first and second tab removably attached to thebase opposite each other. The capillary channel extends from the baseinto a portion of the first tab and the vent channel extends from thebase into a portion of the second tab. The test strip includes a firstbreak line intersecting the capillary channel and a second break lineintersecting the vent channel. An inlet to the capillary channel isexposed when the first tab is separated from the base, whereas a vent tothe vent channel is exposed when the second tab is separated from thebase.

According to yet another embodiment of the present invention, a teststrip to assist in determining the concentration of an analyte in afluid sample is disclosed. The test strip includes a base including acapillary channel and a test element. The capillary channel is in fluidcommunication with the test element. The test element is adapted toreceive the fluid sample. The test strip also includes a tab having abody and at least one extension extending from the body of the tab. Theat least one extension removably attaches the base to the tab. The atleast one extension is adapted to separate from the base when the tab isrotated relative to the base.

According to one embodiment of the present invention, a test strip toassist in determining the concentration of an analyte in a fluid sampleis disclosed. The test strip includes a base including a capillarychannel and a test element. The capillary channel is in fluidcommunication with the test element. The test element is adapted toreceive the fluid sample. The test strip further includes at least onetab removably attached to the base. The at least one tab is locatedperpendicular to the base. The at least one tab being adapted to bendtoward the base to expose an inlet to the capillary channel.

According to another embodiment of the present invention, a meteradapted to incorporate a test strip to assist in determining theconcentration of an analyte in a fluid sample. The meter includes a facehaving a read-head located therein and a plurality of projectionsextending from the face. The plurality of projections are adapted toseat the test strip thereon. The test strip includes (i) a baseincluding a capillary channel and a test element, (ii) at least one tabremovably attached to the base, and (iii) a break line intersecting thecapillary channel. The capillary channel is in fluid communication withthe test element that is adapted to receive the fluid sample. Thecapillary channel extends from the base into a portion of the tab. Aninlet to the capillary channel is exposed along the break line when thetab is separated from the base.

The above summary of the present invention is not intended to representeach embodiment, or every aspect, of the present invention. Additionalfeatures and benefits of the present invention are apparent from thedetailed description and figures set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is an upper perspective view of a test strip, according to oneembodiment of the present invention.

FIG. 1 b is an upper perspective view of the test strip of FIG. 1 aafter the tab has been separated from the base.

FIG. 2 is an upper perspective view of the test strip of FIG. 1 a havinga desiccated cavity, according to another embodiment of the presentinvention.

FIG. 3 is a cross-sectional view of a cartridge adapted to contain aplurality of test strips, according to one embodiment of the presentinvention.

FIG. 4 a is a side view of a test strip having a removably attachedflexible strip, according to yet another embodiment of the presentinvention.

FIG. 4 b is a side view of the test strip of FIG. 4 a having theflexible strip partially separated from the base.

FIG. 5 a is an upper perspective view of a test strip, according to oneembodiment of the present invention.

FIG. 5 b is an upper perspective view of the test strip of FIG. 5 aafter the tabs have been separated from the base.

FIG. 6 a is an upper perspective view of a test strip, according toanother embodiment of the present invention.

FIG. 6 b is an upper perspective view of the test strip of FIG. 6 aafter the tab has been separated from the base.

FIG. 7 a is a side view of a test strip having a foil tab, according toyet another embodiment of the present invention.

FIG. 7 b is a side view of the test strip of FIG. 7 a with the foil tabpartially separated from the base.

FIG. 7 c is an upper perspective view of the test strip of FIG. 7 a withthe foil tab partially separated from the base.

FIG. 8 a is an upper view of a test strip having a plurality of tabstrips, according to one embodiment of the present invention.

FIG. 8 b is an upper view of the test strip of FIG. 8 a having aplurality of tab strips partially separated from the base.

FIG. 9 is an upper view of a test strip, according to another embodimentof the present invention.

FIG. 10 a is a side view of a test strip having a plurality ofdepressions, according to yet another embodiment of the presentinvention.

FIG. 10 b is an upper perspective view of a meter adapted to seat thetest strip of FIG. 10 a.

FIG. 10 c is an upper perspective view of the meter of FIG. 10 b havingthe test strip of FIG. 10 a seated thereon.

FIG. 11 a is an upper perspective view of a test strip and openingdevice, according to one embodiment of the present invention.

FIG. 11 b is a side view of the test strip of FIG. 11 a once the tabshave been partially separated from the base by the opening device.

FIG. 12 a is an upper perspective view of a test strip, according to oneembodiment of the present invention.

FIG. 12 b is an upper perspective view of the test strip of FIG. 12 aafter the tab has been separated from the base.

FIG. 13 a is an upper perspective view of a test strip, according to oneembodiment of the present invention.

FIG. 13 b is an upper perspective view of the test strip of FIG. 13 aonce the tab has been removed, according to one embodiment of thepresent invention.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The present invention is directed to the protection of individual,dry-phase test strips from moisture. The test strips are adapted to beused in conjunction with a meter that can analyze (and in someembodiments, dispense) the test strips. The present invention may beutilized in dry-phase diagnostic test devices and can be applied tohome-use kits, doctors' office kits, and hospital instruments usingdry-phase tests.

The meter and test strip may be used to determine concentrations of atleast one analyte in a fluid sample on the test strip. Analytes that maybe measured using the present invention include glucose, lipid profiles(e.g., cholesterol, triglycerides, LDL and HDL), microalbumin,hemoglobin A₁C, fructose, lactate, bilirubin, or prothrombin. Thepresent invention is not limited, however, to these specific analytesand it is contemplated that other analyte concentrations may bedetermined. The analytes may be in, for example, a whole blood sample, ablood serum sample, a blood plasma sample, other body fluids like ISF(interstitial fluid) and urine, or other (non-body) fluid samples. Asused within this application, the term “concentration” refers to ananalyte concentration, activity (e.g., enzymes and electrolytes), titers(e.g., antibodies), or any other measure concentration used to measurethe desired analyte.

Turning now to the drawings and initially to FIGS. 1 a-b, a test strip10 is illustrated according to one embodiment of the present invention.The test strip 10 comprising a base 12 with a tab 14 removably attachedto the base 12. A capillary channel 16 is provided that is in fluidcommunication with a test element 18. The capillary channel 16 isadapted to transport a fluid sample from a sample site to the testelement 18.

The terms removably attached or attached, as used herein, refer to anyattachment of two sections through any suitable means, wherein the twosections may be separated via force. Further, the terms removablyattached or attached, as used herein, refer to one continuous piece ofmaterial, wherein two portions of the continuous piece of material maybe separated from one another via force.

The test strip 10 also includes recesses 20 a,b located between the base12 and the tab 14. The recesses 20 a,b are provided to facilitate theseparation of the tab 14 from the base 12 of the test strip 10 along abreak line 22. The break line 22 may be created by the recesses 20 a,balone, or the break line 22 may be scored, a cut-line, a line ofweakness, a thinned area/line, etc. The break line 22 intersects aportion of the capillary channel 16. When the tab 14 is separated fromthe base 12 along the break line 22, an inlet 24 is exposed. The inlet24 allows a fluid sample to enter the capillary channel 16 where it istransported to the test element 18. In some embodiments, theintersection of the break line 22 with the capillary channel 16 iswithin the channel itself. In other embodiments, the break line 22intersects above, below, and/or along side the channel and need notphysically touch or be part of the channel.

The test element 18 may contain at least one reactant adapted to reactwith one or more analyte of interest in the fluid sample. The reactionbetween the at least one reactant and the fluid sample may then bemonitored by a meter to determine the concentration of the analyte. Thereaction may designed to be monitored optically or electrochemically.

In some embodiments of the present invention, for example, the testelement 18 could contain reagents adapted for the optical determinationof glucose, such as the enzyme glucose oxidase in combination withindicators such as tetramethylbenzidine or dianisidine or4-aminoantipyrine plus p-hydroxybenzenesulfonate in the presence ofperoxidase. In other embodiments, the enzyme glucose dehydrogenase couldbe used in combination with tetrazolium indicators such asp-iodonitrotetrazolium violet (INT), nitroblue tetrazolium (NBT) ortetranitroblue tetrazolium (TNBT), for example.

In yet other embodiments of the present invention where the analyte ischolesterol, the test element 18 may contain the enzymes cholesterolester hydrolase and cholesterol oxidase plus indicators such astetramethylbenzidine or dianisidine or 4-aminoantipyrine plusp-hydroxybenzenesulfonate in the presence of peroxidase.

In other embodiments, where the analytes are triglycerides, the enzymeslipase, glycerokinase, glycerolphosphate dehydrogenase and diaphorase incombination with tetrazolium indicators such as p-iodonitrotetrazoliumviolet (INT), nitroblue tetrazolium (NBT) or tetranitroblue tetrazolium(TNBT) will produce a color indicative of the triglyceride levels. Inyet other embodiments, the enzymes lipase, glycerokinase, glycerolphosphate oxidase combined with indicators such as tetramethylbenzidineor dianisidine or 4-aminoantipyrine plus p-hydroxybenzenesulfonate inthe presence of peroxidase will produce color in response totriglycerides.

According to other embodiments of the present invention, where theanalyte is the enzyme amylase, the test element may contain, forexample, the enzyme alpha glucosidase and the chromogenic indicator4,6-ethylidene (G7) nitrophenyl (G1)-(alpha)D-maltoheptoside. In stillother embodiments, hemoglobin can be detected using, for example,potassium ferricyanide, potassium cyanide and sodium bicarbonate.

In some embodiments, the test element 18 may contain reagents adaptedfor the electrochemical determination of an analyte concentration. Inthese embodiments, the test element includes at least one appropriatelyselected enzyme to react with the desired analyte or analytes to betested. An enzyme that may be used to electrochemically react withglucose, for example, is glucose oxidase. It is contemplated that otherenzymes may be used such as glucose dehydrogenase. In other embodimentsof the present invention, the test strip 10 may be adapted to allow thedetermination of the concentration of an analyte in a fluid sampleviscosimetrically or thermally.

Upon applying the sample to the test element 18, the analyte reacts withthe at least one reagent located on the test element 18. The reaction isindicative of the analyte concentration in the sample and is evaluatedusing an optical read-head located in a meter. As discussed above, thetest strips of the present invention may be used in combination withmeters having other detection schemes. In other schemes, such as,electrochemical, etc. different reactants may be applied to the testelement 18 to generate the desired reaction.

The test element 18 is adapted to be placed into contact with the fluidsample (e.g., a whole blood sample) to be tested. The whole blood samplemay be generated by a lancing device such as a lancet. The whole bloodsample may be obtained by a lancet that may be separate from the meteror may be integrated within the meter. The lancing device may obtainblood by, for example, pricking a person's finger.

Referring now to FIG. 2, a test strip 30 is illustrated according to oneembodiment of the present invention. The test strip 30 includes a cavity36 within the tab 34 of the test strip 30. The cavity 36 is connected tothe capillary channel 16, and thus, is in communication with the testelement 18. The cavity 36 may contain a desiccant 38 for removingmoisture from the test element 18, capillary channel 16, and cavity 36.The desiccant 38 may be, for example, a desiccant bead or hot meltdesiccant plug, located in the cavity 36. In other embodiments, thecavity 36 and the desiccant 38 are located within the base 12 of thetest strip 10 yet remain in gaseous communication with both the testelement 18 and the capillary channel 16. After the tab 34 has beenremoved, the test strip 30 is identical to the test strip 10 shown inFIG. 1 b.

In the embodiments of FIGS. 1-2, the test strips are self-containedampoules. An ampoule is a small container that is sealed to the externalelements. As discussed with respect to FIG. 2, a desiccant may beprovided in the ampoule. Thus, the test strips of the present inventiondo not require an instrument designer to devise a reliable, resealableinner cartridge to hold the test strips. The test strips may belaminated or may be molded and formed to the designs illustrated above.The base 12 of the test strips may be made of any suitable material, asis generally known within the art. For example, where the reactionbetween the reactants and the fluid sample is to be monitored optically,the base 12 of the test strip may be designed from an optically clearmaterial, such as, optically clear polyethylene terephthalate (PET).

The tab 14 of the test strips may be a stiff plastic, or alternatively,a flexible material that can be punctured or torn to reveal the inlet 24to the capillary channel 16.

Turning now to FIG. 3, a cartridge 40 adapted to store and eject aplurality of test strips 10 is illustrated, according to one embodiment.The cartridge 40 includes an opening 42 adapted to allow a test strip 10to be ejected therefrom. The cartridge 40 includes an ejection mechanism(not shown) for allowing a user to eject a test strip 10 from thecartridge 40. The ejection mechanism is adapted to eject a test strip 10such that at least the tab 14 and the break line 22 are external fromthe cartridge 40 after the test strip 10 has been ejected.

Once the test strip 10 has been ejected, a user may expose the inlet 24by tearing, puncturing, ripping, or otherwise separating the tab 14 fromthe base 12. Alternatively, the tab 14 may be separated from the base 12during the ejection of the test strip 10 from the cartridge 40. Once thetab 14 has been separated, a user may bring the inlet 24 of the base 12into contact with a fluid sample. The fluid sample is then transportedto the test element 18 and the test strip 10 may be repositioned—eithermanually or by the cartridge 40 or meter—so that the meter is able todetermine the analyte concentration in the fluid sample.

Turning now to FIGS. 4 a-b, a test strip 50 is illustrated having aflexible strip 52 attached thereto. The flexible strip 52 is removablyattached to the base 12 and is attached to the tab 14 of the test strip50. As illustrated in FIGS. 4 a-b, when the tab 14 is separated from thebase 12 to expose the inlet 24, the flexible strip 52 allows the tab 14and base 12 to remain an unified piece. Thus, the tab 14 would bediscarded along with the base 12 when the test strip 50 is no longerrequired. Alternatively, in other embodiments, the flexible strip 52 iscompletely separated from the base 12 while remaining attached to thetab 14.

Turning now to FIGS. 5 a-b, a test strip 60 is illustrated according toone embodiment of the present invention. The test strip 60 includes avent channel 62 that is in gaseous communication with the test element18 and the capillary strip 16. The vent channel 62, when exposed, allowsair to escape from the capillary channel 16 and test element 18 as afluid sample enters. The test strip 60 includes a second tab 64 and asecond set of recesses 20 c,d that facilitate the separation of thesecond tab 64 from a base 66 along a second break line 68. Theseparation of the second tab 64 from the base 66 exposes a vent 67 atthe end of the base 66 along the break line 68. In this embodiment, auser or the device separates both the first tab 14 and the second tab 64from the base 66 to expose an inlet 24 (FIG. 1 b) and the vent 67. As afluid sample enters the inlet 24, the displaced gas from the capillarychannel 16 and the test element 18 are allowed to escape through thevent channel 62 and out the vent 67.

Referring now to FIGS. 6 a-b, a venting channel 62 is illustrated withina test strip 70, according to another embodiment of the presentinvention. The test strip 70 is designed to allow a single separation ofa tab 74 from a base 72 to expose both an inlet 24 and a vent 67. Asillustrated in FIG. 6 a, the break line 22 intersects both the capillarychannel 16 and the vent channel 62.

Turning now to FIGS. 7 a-c, a test strip 80 is illustrated according toone embodiment of the present invention. A base 81 of the test strip 80includes a capillary channel 16, a test element 18, and a vent channel62, as shown in FIG. 1 a. A tab 82 of the test strip 80 is removablyattached to an upper surface 86 of the base 81. The tab 82 includes alip or extension 88 that extends from the tab 82 past the base 81. Thelip 88 is adapted to allow a user or device to remove the tab 82 fromthe base 81. For example, a user may grasp the lip 88 and peel the tab82 from the base 81. When the tab 82 has been sufficiently removed fromthe base 81, an inlet 24 and a vent 84 are exposed, as is bestillustrated in FIG. 7 b-c.

The tab 82 may be designed from any suitable material. For example, thetab 82 may be made of standard foil. The tab 82 may be attached to thebase 81, for example, by an adhesive (e.g., pressure-sensitive adhesive,hot-mount adhesive, etc.) The tab 82 may be designed so as to removeentirely from the base 81 or may remain partially attached to the base81, as shown in FIGS. 7 b-c.

Turning now to FIGS. 8 a-b, a test strip 90 is illustrated according toone embodiment of the present invention. The test strip 90 includes afirst tab strip 94 a and a second tab strip 94 b. The tab strips 94 a,bcover an inlet 24 and a vent 84 respectively. The tab strips 94 a,b areremovably attached to an upper surface 86 of the base 82 of the teststrip 90. Each tab strip 94 a,b includes a lip or extension 96 a,brespectively that extends beyond the base 82, as illustrated in FIG. 8a. The tab strips 94 a,b may be peeled from the base 82, for example, bygrasping the extensions 96 a,b and pulling the tab strips 94 a,b backacross the base 82, opposite the original position of the extensions 96a,b in FIG. 8 a.

The tab strips 94 a,b may be designed from any suitable material, suchas the materials described above with respect to tab 82 in FIGS. 7 a-c.Additionally, a string or an oriented polymer may be embedded in the tabstrips 94 a,b to provide support when peeling the tab strips 94 a,b. Thetab strips 94 a,b may be designed so as to remove entirely from the base82 or may remain attached to the base 82 as shown in FIG. 8 b.

Turning now to FIG. 9, a test strip 100 is illustrated according toanother embodiment of the present invention. The test strip 100 includesa notch 106 located between a base 102 and a tab 104. The notch 106 isadapted to allow the tab 104 to be torn from the base 102 along thebreak line 22. After the tab 104 has been removed, the test strip 100 issimilar to the test strip 10 shown in FIG. 1 b.

Turning now to FIG. 10 a, a test strip 110 is illustrated according toone embodiment of the present invention. The test strip 110 includes abase 112 located between a first tab 114 and a second tab 116. A firstdepression 118 a is between the first tab 114 and the base 112 and asecond depression 118 b is located between the second tab 116 and thebase 112. The depressions 118 a,b are adapted to allow an inlet (notshown) and a vent (not shown) to be exposed along the respective breaklines 22, 66.

Referring now to FIG. 10 b, a meter 120 is illustrated according to oneembodiment of the present invention. The meter 120 is adapted to seatthe test strip 110 of FIG. 10 a. The meter 120 may be a generallyrectangular box (though other designs are known and may be adapted foruse with the present invention). The meter 120 includes a face 122having a read-head 124 located therein. The read-head 124 may be used toanalyze a fluid sample located on the test strip 110. The meter 120includes a plurality of projections 126 a,b that are adapted to engagethe base 112 of the test strip 110. The projections 126 a,b are designedto position the test element 18 of the test strip 110 proximate theread-head 124 of the meter 120.

Once the test strip 110 has been seated on the meter 120, the first andsecond tabs 114,116 may be separated from the base 112 along the breaklines 22,66, as illustrated in FIG. 10 c. The meter 120 facilitatesseparation of the tabs 114,116 from the base 112 by holding the base 112in position as a pressure is applied to the tabs 114,116 in thedirection of the meter 120. The tabs 114,116 may be completely separatedfrom the base 112, or the tabs 114,116 may remain attached to the base112 as illustrated in FIG. 10 c. The bending of the tabs 114,116 may beeffected either manually or mechanically. Mechanical bending of the tabs114,116 can be effected by a moving piece within the meter 120, ormovement of the test strip 110 within the meter 120 against stationaryprojections which perform the bending of the tabs 114,116.

Referring now to FIGS. 11 a-b, a test strip 130 and opening device 140are illustrated according to one embodiment of the present invention.The opening device 140 may be incorporated into a meter that can be usedto read the test element and determine the concentration of one or moreanalyte in a fluid sample. The test strip 130 includes one or more tabs134. In the illustrated embodiment, the test strip 130 includes two tabs134 a,b. The tabs 134 are located perpendicular to the base 132 and maybe triangular (as shown) or any other suitable shape. As the test strip130 is moved past the opening device 140, for example, as the test stripis being moved to a ready position or ejected from a cartridge, the tabs134 are brought into contact with the opening device 140 and are benttoward the base 132, thus, exposing an inlet 24 and/or vent 67 along thebreak lines 134 a,b, as illustrated in FIG. 11 b.

As discussed above, an instrument or meter can perform the automaticopening of the test strip as the test strip is moved to a ready area forinoculation by a fluid sample. For example, according to someembodiments, a foil tab located above the base with a slight gap allowsthe instrument or meter to passively open the sensor with a knife orblade as the test strip is moved into the ready area. Alternatively, insome embodiments where a gear is used to move the test strip to theready area, a sprocket could expose a vent and inlet by poking throughthe tab as the test strip is being positioned.

Turning now to FIGS. 12 a-b, a test strip 150 is illustrated accordingto another embodiment of the present invention. The test strip 150 is atwist-off test strip having a base 152 removably attached to a tab 154.The tab 154 includes one or more extensions 156. In the illustratedembodiment, the tab 154 includes two extensions 156 a,b that extend froma body 158 of the tab 154. The extensions 156 a,b are removably attachedto the base 152, thus, attaching the base 152 to the tab 154. Theextensions 156 a,b are attached to the base 152 at an inlet 24 and/or ata vent 67 to seal one or more of the capillary channel 16 or the ventchannel 62.

To expose the inlet and/or vent, a user or instrument may rotate the tab154 around an axis running (in the embodiment illustrated in FIG. 12 a)between, and parallel to, the extensions 156 a,b. For example, byrotating the tab 154 in the direction of arrow A. Alternatively, the tab154 may be rotated opposite arrow A. The tab 154 and/or base 152 may bedesigned from a soft-plastic to facilitate the removal of the tab 154from the base 152 when the tab 154 is rotated.

Referring now to FIGS. 13 a-b, a test strip 160 is illustrated accordingto one embodiment of the present invention. The test strip 160 issimilar to the test strip 10 described in FIGS. 1 a-b. However, in someembodiments, like the embodiment illustrated in FIGS. 13 a-b, the teststrip 160 includes protrusion 162 that extends from the base 12 andextends the capillary channel 16 such that an inlet 164 is removed fromthe base 12. In these embodiments, the protrusion 162 helps to preventor inhibit contamination of a meter or read-head by a sample when thesample is being applied with the test strip 160 positioned on the meter.

In some embodiments of the present invention, the above-describedprotrusion 162 is incorporated into each of the above-described teststrips. In some embodiments where the test strip includes a ventchannel, it is desirable to prevent a fluid sample from entering thevent channel. If the fluid sample is allowed to enter the vent channel,a larger fluid sample is required. However, when the fluid sample isbeing obtained directly from a user (e.g., a blood sample from theuser's fingertip) it may be desirable to reduce the volume of therequired fluid. Thus, in embodiments having a vent channel, it may bedesirable to prevent or inhibit the fluid sample from entering the ventchannel.

Additionally, in some embodiments the capillary channel is treated toassist in transporting the fluid sample to the test element. Forexample, the capillary channel may be treated with a hydrophiliccoating, a hydrophilic mesh, or a hydrophilic graft polymer. Inembodiments where the fluid sample is blood, the capillary channel maybe treated with plasma or corona discharge to induce the blood drop toenter.

One method to assist in preventing or inhibiting the fluid sample fromentering the vent channel is to treat only the capillary channel asdiscussed above, while not treating the vent channel. Alternatively oradditionally, the vent channel could be blocked by a hydrophobic airpermeable material (e.g., mesh, scintered plastic bead membrane such asPorex, scintered metal or metal sponge, hydrophobic venting membranessuch as teflon or polyolefins, etc.), a hydrophobic stripe (e.g., hotmelt or laminated hydrophobic plastic), a chemical treatment to renderhydrophobicity, or by removing any pretreatment by physical means (e.g.,laser ablation, localized heating, or mechanical scoring).

Another method to assist in preventing the fluid sample from enteringthe vent channel is to vary the depth of the vent channel in comparisonto the test element. For example, the vent channel could be deeper thanthe test element and the resulting height differential would prevent orinhibit fluid sample flow into the vent channel.

According to some embodiments of the present invention, the integrity ofeach strip can be automatically tested by a meter. For example, in someembodiments, a colorimetric indicator that would indicate the presenceof an undesirable substance (e.g., water, etc.) can be used to determinethe strip integrity. The indicator could be read by a read-head withinthe meter—the same read-head used to read the test element once thefluid sample has been applied. In this way, an objective determinationas to the integrity of the test strip can be made. In other embodiments,automated electrochemical determinations of desiccant saturation can bemade. For example, in electrochemical systems, desiccant moisturecontent (indicating strip integrity) may be determined byelectrochemical means (e.g., conductance, resistance, impedance,capacitance, etc.) sensitive to water content.

While the invention is susceptible to various modifications andalternative forms, specific embodiments and methods thereof have beenshown by way of example in the drawings and are described in detailherein. It should be understood, however, that it is not intended tolimit the invention to the particular forms or methods disclosed, but,to the contrary, the intention is to cover all modifications,equivalents and alternatives falling within the spirit and scope of theinvention.

Alternative Embodiment A

A test strip to assist in determining the concentration of an analyte ina fluid sample, comprising:

a base including a capillary channel and a test element, the capillarychannel being in fluid communication with the test element, the testelement being adapted to receive the fluid sample;

at least one tab removably attached to the base, the capillary channelextending from the base into a portion of the tab; and

a break line intersecting the capillary channel, wherein an inlet to thecapillary channel is exposed along the break line when the tab isseparated from the base.

Alternative Embodiment B

The test strip of Alternative Embodiment A further comprising at leastone recess located between the base and the at least one tab, the atleast one recess being adapted to facilitate the separation of the atleast one tab from the base along the break line.

Alternative Embodiment C

The test strip of Alternative Embodiment B further comprising a secondrecess located between the base and the at least one tab opposite the atleast one recess, the at least one recess and second recess facilitatingthe separation of the at least one tab from the base along the breakline.

Alternative Embodiment D

The test strip of Alternative Embodiment A wherein the at least one tabincludes a cavity having a desiccant located therein, the cavity beingin gaseous communication with the capillary channel and the testelement.

Alternative Embodiment E

The test strip of Alternative Embodiment A wherein the base includes avent channel, the vent channel being in communication with the testelement and the capillary channel.

Alternative Embodiment F

The test strip of Alternative Embodiment E wherein the at least one tabincludes a cavity having a desiccant located therein, the cavity beingin gaseous communication with the capillary channel, the test element,and the vent channel.

Alternative Embodiment G

The test strip of Alternative Embodiment E wherein the at least one tabincludes a cavity having a desiccant located therein, the cavity beingin liquid communication with the capillary channel, the test element,and the vent channel.

Alternative Embodiment H

The test strip of Alternative Embodiment E wherein the vent channelincludes a desiccant located therein.

Alternative Embodiment I

The test strip of Alternative Embodiment E wherein the break lineintersects the vent channel.

Alternative Embodiment J

The test strip of Alternative Embodiment I wherein a vent to the ventchannel is exposed along the break line when the at least one tab isseparated from the base.

Alternative Embodiment K

The test strip of Alternative Embodiment E further comprising a secondtab removably attached to the base opposite the at least one tab, thevent channel extending from the base into the second tab.

Alternative Embodiment L

The test strip of Alternative Embodiment K wherein a vent is exposedwhen the second tab is separated from the base.

Alternative Embodiment M

The test strip of Alternative Embodiment A further comprising a flexiblestrip removably attached to the base, the flexible strip at leastpartially separating from the base when the at least one tab isseparated from the base, the flexible strip remaining attached to the atleast one tab.

Alternative Embodiment N

The test strip of Alternative Embodiment A further comprising a notchadapted to facilitate the tearing of the at least one tab from the basealong the break line.

Alternative Embodiment O

The test strip of Alternative Embodiment A wherein the break line isformed by scoring the test strip.

Alternative Embodiment P

The test strip of Alternative Embodiment A wherein the break line isformed by a cut line in the test strip.

Alternative Embodiment Q

The test strip of Alternative Embodiment A wherein the break line isformed by a line of weakness along the test strip.

Alternative Embodiment R

The test strip of Alternative Embodiment A wherein the break line isformed by a thinned area of the test strip.

Alternative Embodiment S

The test strip of Alternative Embodiment A wherein the test elementcontains a desiccant in gaseous communication with the test element.

Alternative Embodiment T

The test strip of Alternative Embodiment A wherein the test elementcontains a desiccant in liquid communication with the test element.

Alternative Process U

A method for using a test strip to determine a concentration of ananalyte in a fluid sample, the method comprising the acts of:

providing a test strip including

(i) a base including a capillary channel and a test element, thecapillary channel being in fluid communication with the test element,the test element being adapted to receive the fluid sample,

(ii) at least one tab removably attached to the base, the capillarychannel extending from the base into a portion of the tab, and

(iii) a break line intersecting the capillary channel;

exposing an inlet to the capillary channel by at least partiallyseparating the at least one tab from the base.

Alternative Process V

The method of Alternative Process U wherein an opening device is used toexpose the inlet.

Alternative Process W

The method of Alternative Process U wherein the at least one tab is atleast partially separated from the base by a meter.

Alternative Process X

The method of Alternative Process U wherein the at least one tab is atleast partially separated from the base by twisting the at least one tabrelative to the base.

Alternative Process Y

The method of Alternative Process U wherein the at least one tab is atleast partially separated from the base by tearing the test strip alongthe break line.

Alternative Process Z

The method of Alternative Process U wherein the at least one tab is atleast partially separated from the base by bending the test strip at thebreak line.

Alternative Process AA

The method of Alternative Process U wherein the at least one tab is atleast partially separated from the base by slicing the test strip at thebreak line.

Alternative Process AB

The method of Alternative Process U wherein the at least one tab is atleast partially separated from the base by pulling the at least one tabaway from the base.

Alternative Embodiment AC

A test strip to assist in determining the concentration of an analyte ina fluid sample, comprising:

a base including a capillary channel and a test element, the capillarychannel being in fluid communication with the test element, the testelement being adapted to receive the fluid sample;

a tab removably attached to the base, the capillary channel extendingfrom the base into a portion of the tab;

a protrusion extending from the base into the tab, the protrusion beingan extension of the capillary channel into the tab; and

a break line intersecting the capillary channel, wherein an inlet to thecapillary channel is exposed when the tab is separated from the base,the inlet being located at the end of the protrusion opposite the base.

Alternative Embodiment AD

The test strip of Alternative Embodiment AC further comprising at leastone recess located between the base and the tab, the at least one recessbeing adapted to facilitate the separation of the tab from the basealong the break line.

Alternative Embodiment AE

The test strip of Alternative Embodiment AC wherein the tab includes acavity having a desiccant located therein, the cavity being in gaseouscommunication with the capillary channel and the test element.

Alternative Embodiment AF

The test strip of Alternative Embodiment AC wherein the tab includes acavity having a desiccant located therein, the cavity being in liquidcommunication with the capillary channel and the test element.

Alternative Embodiment AG

The test strip of Alternative Embodiment AC wherein the base includes avent channel, the vent channel being in communication with the testelement and the capillary channel.

Alternative Embodiment AH

The test strip of Alternative Embodiment AG wherein the tab includes acavity having a desiccant located therein, the cavity being in gaseouscommunication with the capillary channel, the test element, and the ventchannel.

Alternative Embodiment AI

The test strip of Alternative Embodiment AG wherein the vent channelincludes a desiccant located therein.

Alternative Embodiment AJ

The test strip of Alternative Embodiment AG wherein the break lineintersects the vent channel.

Alternative Embodiment AK

The test strip of Alternative Embodiment AJ wherein a vent to the ventchannel is exposed when the tab is separated from the base.

Alternative Embodiment AL

The test strip of Alternative Embodiment AC further comprising a notchadapted to facilitate the tearing of the tab from the base along thebreak line.

Alternative Embodiment AM

A test strip to assist in determining the concentration of an analyte ina fluid sample, comprising:

a base including an upper surface, a capillary channel, a test element,and a desiccant, the capillary channel being in fluid communication withthe test element, the test element being adapted to receive the fluidsample; and

at least one tab removably attached to the upper surface of the base,the at least one tab including a lip that extends from the base, the lipbeing adapted to allow the at least one tab to be separated such thatthe separation from the base exposes an inlet to the capillary channel.

Alternative Embodiment AN

The test strip of Alternative Embodiment AM wherein the base includes acavity, the desiccant being located within the cavity, the cavity beingin gaseous communication with the capillary channel and the testelement.

Alternative Embodiment AO

The test strip of Alternative Embodiment AM wherein the base includes avent channel, the vent channel being in communication with the testelement and the capillary channel.

Alternative Embodiment AP

The test strip of Alternative Embodiment AO wherein the base includes acavity, the desiccant being located within the cavity, the cavity beingin gaseous communication with the capillary channel, the test element,and the vent channel.

Alternative Embodiment AQ

The test strip of Alternative Embodiment AO wherein the base includes acavity, the desiccant being located within the cavity, the cavity beingin liquid communication with the capillary channel, the test element,and the vent channel.

Alternative Embodiment AR

The test strip of Alternative Embodiment AO wherein the desiccant islocated within the vent channel.

Alternative Embodiment AS

The test strip of Alternative Embodiment AO wherein the separation ofthe at least one tab from the base exposes a vent to the vent channel.

Alternative Embodiment AT

The test strip of Alternative Embodiment AM further comprising a secondtab, the second tab including a second lip that extends from the base,the second lip being adapted to allow the second tab to be separatedfrom the base.

Alternative Embodiment AU

The test strip of Alternative Embodiment AO wherein the separation ofthe at least one tab from the base exposes an inlet to the capillarychannel while the separation of the second tab from the base exposes avent of the vent channel.

Alternative Embodiment AV

A test strip to assist in determining the concentration of an analyte ina fluid sample, comprising:

a base including a capillary channel, a test element, and a ventchannel, the test element being adapted to receive the fluid sample, thecapillary channel, test element, and vent channel being in communicationwith one another;

a first tab removably attached to the base, the capillary channelextending from the base into a portion of the first tab;

a second tab removably attached to the base, the second tab beinglocated opposite the base from the first tab, the vent channel extendingfrom the base into a portion of the second tab;

a first break line intersecting the capillary channel, wherein an inletto the capillary channel is exposed when the first tab is separated fromthe base; and

a second break line intersecting the vent channel, wherein a vent to thevent channel is exposed when the second tab is separated from the base.

Alternative Embodiment AW

The test strip of Alternative Embodiment AV further comprising a firstdepression located between the base and the first tab, the firstdepression facilitating the separation of the first tab from the basealong the first break line.

Alternative Embodiment AX

The test strip of Alternative Embodiment AW further comprising a seconddepression located between the base and the second tab, the seconddepression facilitating the separation of the second tab from the basealong the second break line.

Alternative Embodiment AY

A test strip to assist in determining the concentration of an analyte ina fluid sample, comprising:

a base including a capillary channel and a test element, the capillarychannel being in fluid communication with the test element, the testelement being adapted to receive the fluid sample; and

a tab having a body and at least one extension extending from the bodyof the tab, the at least one extension removably attaching the base tothe tab,

wherein the at least one extension is adapted to separate from the basewhen the tab is rotated relative to the base.

Alternative Embodiment AZ

The test strip of Alternative Embodiment AY wherein the base includes acavity having a desiccant located therein, the cavity being in gaseouscommunication with the capillary channel and the test element.

Alternative Embodiment BA

The test strip of Alternative Embodiment AY wherein the base includes avent channel, the vent channel being in communication with the testelement and the capillary channel.

Alternative Embodiment BB

The test strip of Alternative Embodiment BA wherein the base includes acavity having a desiccant located therein, the cavity being in gaseouscommunication with the capillary channel, the test element, and the ventchannel.

Alternative Embodiment BC

The test strip of Alternative Embodiment BA wherein the vent channelincludes a desiccant located therein.

Alternative Embodiment BD

The test strip of Alternative Embodiment AY wherein an inlet to thecapillary channel is exposed when the at least one extension isseparated from the base.

Alternative Embodiment BE

The test strip of Alternative Embodiment BA wherein a vent to the ventchannel is exposed when the at least one extension is separated from thebase.

Alternative Embodiment BF

A test strip to assist in determining the concentration of an analyte ina fluid sample, comprising:

a base including a capillary channel and a test element, the capillarychannel being in fluid communication with the test element, the testelement being adapted to receive the fluid sample; and

at least one tab removably attached to the base, the at least one tabbeing located perpendicular to the base, the at least one tab beingadapted to bend toward the base to expose an inlet to the capillarychannel.

Alternative Embodiment BG

The test strip of Alternative Embodiment BF wherein the base includes avent channel, the vent channel being in communication with the testelement and the capillary channel.

Alternative Embodiment BH

The test strip of Alternative Embodiment BG wherein the at least one tabis bent toward the base by an opening device.

Alternative Embodiment BI

The test strip of Alternative Embodiment BG wherein the opening deviceis incorporated into a meter adapted to read the test element anddetermine the analyte concentration in the fluid sample.

Alternative Embodiment BJ

The test strip of Alternative Embodiment BG wherein the at least one tabis bent toward the base as the test strip is being move to a readyposition.

Alternative Embodiment BK

The test strip of Alternative Embodiment BG wherein the at least one tabis bent toward the base as the test strip is being ejected from acartridge.

Alternative Embodiment BL

The test strip of Alternative Embodiment BF wherein the at least one tabis substantially triangular.

Alternative Embodiment BM

A meter adapted to incorporate a test strip to assist in determining theconcentration of an analyte in a fluid sample, the meter comprising:

a face having a read-head located therein; and

a plurality of projections extending from the face, the plurality ofprojections being adapted to seat the test strip thereon, the test stripincluding

(i) a base including a capillary channel and a test element, thecapillary channel being in fluid communication with the test element,the test element being adapted to receive the fluid sample,

(ii) at least one tab removably attached to the base, the capillarychannel extending from the base into a portion of the tab; and

(iii) a break line intersecting the capillary channel, wherein an inletto the capillary channel is exposed along the break line when the tab isseparated from the base.

Alternative Embodiment BN

The meter of Alternative Embodiment BM wherein the meter facilitates theseparation of the at least one tab from the base of the test strip.

Alternative Embodiment BO

The meter of Alternative Embodiment BM wherein the test element of thetest strip is proximate the read-head of the meter when the test stripis seated on the meter.

While the invention is susceptible to various modifications andalternative forms, specific embodiments are shown by way of example inthe drawings and are described in detail herein. It should beunderstood, however, that the invention is not intended to be limited tothe particular forms disclosed. Rather, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the invention as defined by the appended claims.

The invention claimed is:
 1. A test strip cartridge, comprising: ahousing including an opening; an ejection mechanism configured to ejecta test strip from the housing and through the opening; and a pluralityof test strips positioned within the housing, each of the plurality oftest strips having: a base including a capillary channel having at leastone interior surface with a reagent deposited thereon; a tab removablyattached to an end of the base, the capillary channel extending from thebase into a portion of the tab such that the tab includes a portion ofthe capillary channel; and a break line intersecting the capillarychannel, wherein an inlet to the capillary channel is configured to beexposed along the break line in response to the tab being at leastpartially separated from the base.
 2. The test strip cartridge of claim1, wherein each of the plurality of test strips further has at least onerecess located between the base and the tab, the at least one recessbeing adapted to facilitate the separation of the tab from the basealong the break line.
 3. The test strip cartridge of claim 1, whereinthe tab of each of the plurality of test strips includes a cavity havinga desiccant located therein, the cavity being in communication with thecapillary channel and the reagent.
 4. The test strip cartridge of claim1, wherein the base of each of the plurality of test strips includes avent channel in communication with the capillary channel.
 5. The teststrip cartridge of claim 4, wherein the break line of each of theplurality of test strips intersects the vent channel.
 6. The test stripcartridge of claim 5, wherein a vent to the vent channel of each of theplurality of test strips is configured to be exposed along the breakline in response to the tab being at least partially separated from thebase.
 7. The test strip cartridge of claim 4, wherein each of theplurality of test strips further comprises a second tab removablyattached to a second end of the base opposite the first end of the base,the vent channel extending from the base into the second tab such thatthe second tab includes a portion of the vent channel.
 8. The test stripcartridge of claim 7, wherein a vent to the vent channel of each of theplurality of test strips is configured to be exposed in response to thesecond tab being at least partially separated from the base.
 9. The teststrip cartridge of claim 1, wherein the break line of each of theplurality of test strips is formed by a line of weakness along the teststrip.
 10. The test strip cartridge of claim 1, wherein the break lineof each of the plurality of test strips is formed by scoring the teststrip.
 11. The test strip cartridge of claim 1, wherein the break lineof each of the plurality of test strips is formed by a cut line in thetest strip.
 12. The test strip cartridge of claim 1, wherein the breakline of each of the plurality of test strips is formed by a thinned areaof the test strip.
 13. The test strip cartridge of claim 1, wherein theejection mechanism is configured to eject the test strip such that atleast the tab and the break line of the test strip are external from thehousing after the test strip is ejected.
 14. A method of using a teststrip cartridge, comprising: ejecting one of a plurality of test stripsfrom a test strip cartridge through an opening of a housing of the teststrip cartridge using an ejection mechanism of the test strip cartridge,the ejected test strip comprising (i) a base including a capillarychannel having at least one interior surface with a reagent depositedthereon, (ii) a tab removably attached to an end of the base, thecapillary channel extending from the base into a portion of the tab suchthat the tab includes a portion of the capillary channel, and (iii) abreak line intersecting the capillary channel; and exposing an inlet tothe capillary channel along the break line by at least partiallyseparating the tab from the base.
 15. The method of claim 14, furthercomprising receiving a fluid sample through the inlet such that thefluid sample flows through the capillary channel and contacts thereagent.
 16. The method of claim 14, wherein the tab is at leastpartially separated from the base by moving the base within a meterhaving projections positioned to apply pressure to the tab.
 17. Themethod of claim 14, wherein the tab is at least partially separated fromthe base by twisting the tab relative to the base.
 18. The method ofclaim 14, wherein the tab is at least partially separated from the baseby tearing the test strip along the break line.
 19. The method of claim14, wherein the tab is at least partially separated from the base bybending the test strip at the break line.
 20. The method of claim 14,wherein the tab is at least partially separated from the base by slicingthe test strip at the break line.
 21. The method of claim 14, whereinthe tab is at least partially separated from the base by pulling thefirst tab away from the base.
 22. The method of claim 14, wherein theejecting comprises ejecting the one of the plurality of test strips suchthat at least the tab and the break line of the one of the plurality oftest strips are external from the housing.